Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127881631 | 12788163 | 1 | I | 201607 | 20160919 | 20160928 | 20160928 | PER | PHEH2016US024038 | NOVARTIS | 38.45 | YR | F | Y | 61.23000 | KG | 20160928 | CN | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127881631 | 12788163 | 1 | PS | FEMARA | LETROZOLE | 1 | Oral | 2.5 MG, QD (EVERY BEDTIME) | Y | 20726 | 2.5 | MG | TABLET | QD | |||||
| 127881631 | 12788163 | 2 | C | CALTRATE WITH VITAMIN D | CALCIUM CARBONATECHOLECALCIFEROL | 1 | Oral | 1 DF, BID | U | 0 | 1 | DF | TABLET | BID | |||||
| 127881631 | 12788163 | 3 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 50 UG, QD (EVERY MORNING ON AN EMPTY STOMACH) | U | 0 | 50 | UG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127881631 | 12788163 | 1 | Breast cancer metastatic |
| 127881631 | 12788163 | 2 | Product used for unknown indication |
| 127881631 | 12788163 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127881631 | 12788163 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127881631 | 12788163 | Abdominal pain upper | |
| 127881631 | 12788163 | Abdominal tenderness | |
| 127881631 | 12788163 | Anxiety | |
| 127881631 | 12788163 | Bone lesion | |
| 127881631 | 12788163 | Breast cancer metastatic | |
| 127881631 | 12788163 | Breast cancer recurrent | |
| 127881631 | 12788163 | Cholelithiasis | |
| 127881631 | 12788163 | Dizziness | |
| 127881631 | 12788163 | Fatigue | |
| 127881631 | 12788163 | Gallbladder enlargement | |
| 127881631 | 12788163 | Headache | |
| 127881631 | 12788163 | Malaise | |
| 127881631 | 12788163 | Malignant neoplasm progression | |
| 127881631 | 12788163 | Mass | |
| 127881631 | 12788163 | Metastases to bone | |
| 127881631 | 12788163 | Musculoskeletal chest pain | |
| 127881631 | 12788163 | Nodule | |
| 127881631 | 12788163 | Osteoarthritis | |
| 127881631 | 12788163 | Pleural fibrosis | |
| 127881631 | 12788163 | Pneumonitis | |
| 127881631 | 12788163 | Procedural pain | |
| 127881631 | 12788163 | Scar | |
| 127881631 | 12788163 | Soft tissue mass | |
| 127881631 | 12788163 | Spinal osteoarthritis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127881631 | 12788163 | 1 | 201601 | 0 |